European Commission Expands Approval for AstraZeneca’s Heart Failure Drug

The European Commission has expanded its approval of AstraZeneca’s heart failure drug Forixga (dapaglifozin) for use in patients with mildly reduced or preserved left ventricular ejection fraction (LVEF), an important measure of heart function. The drug was previously indicated in use for heart failure patients with reduced LVEF and type 2 diabetes.

According to Emily Kimber, “The European Commission’s decision, which follows a recommendation from the Committee for Medicinal Products for Human Use in December last year, is supported by results from AZ’s phase 3 DELIVER trial, which evaluated the Forixga in HF patients with LVEF greater than 40%, with or without type 2 diabetes. The study showed that Forixga, in addition to standard care, improved symptom burden, physical limitations and quality of life compared to placebo, with benefits achieved from as early as one month and sustained at eight..”

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(Source: PM Live, February 8^th, 2023)